Johnson & Johnson set to seek authorization for its booster shot

COVID-19 vaccine

FILE – In this April 8, 2021, file photo, registered nurse fills a syringe with the Johnson & Johnson COVID-19 vaccine at a pop up vaccination site in the Staten Island borough of New York. (AP Photo/Mary Altaffer, File)

(NEXSTAR) — Johnson & Johnson plans to ask federal regulators early this week for authorization of its COVID-19 booster shot, The New York Times reported Monday. The news is according to officials familiar with the company’s plans.

Last month, regulators authorized a booster shot for some recipients of the Pfizer-BioNTech’s vaccine and are considering authorization this month for recipients of the Moderna vaccine.

Federal officials are concerned that the more than 15 million U.S. recipients of the J&J vaccine are at too great a risk of severe COVID-19, the Times reported.

The Food and Drug Administration on Friday scheduled an Oct. 15 meeting of its advisory committee to discuss whether to grant emergency use authorization of a J&J booster shot.

The U.S. Centers for Disease Control and Prevention says you’re fully vaccinated two weeks after receiving a second dose of the Pfizer or Moderna vaccine, or one J&J dose.

Though the vaccines offer strong protection against serious illness, U.S. health officials now recommend boosters for some people at higher risk for severe illness from COVID-19 based on evidence that protection against milder disease can wane, especially among older adults.

The CDC says people 65 and older, long-term care residents and others ages 50 to 64 with health problems such as diabetes or heart disease should get boosters if they got Pfizer shots at least six months ago.

The agency stopped short of recommending boosters for people 18 to 49 with health problems but says they can also get the shot after considering their individual risk. The same is true for anyone 18 to 64 whose job could put them at higher risk for infection, such as health care workers, teachers, first responders, agriculture workers and public transit workers.

Last month, Johnson and Johnson announced that a second dose of its vaccine boosts efficacy by about 22% percentage points, to 94%, when given two months after the first.

“Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases,” Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson, said in a statement at the time.

The Associated Press contributed to this report.


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